Lybrido for Female Sexual Dysfunction

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The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week baseline establishment period, 16 week treatment period and a follow up period for a total of 26 weeks on study. Subjects are randomly to one of seven treatment arms. The study investigates the effective dose of Lybrido in increasing the number of satisfactory sexual episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire disorder and low sensitivity for sexual cues (30 subjects per group).

The number of satisfactory sexual encounters based on event questionnaires on active drug as compared to placebo during double-blind treatment period episodes in the domestic setting. [ Time Frame: 20 weeks ]

Efficacy is estimated by self reporting by subjects using daily event questionnaires, recorded within 24 hours after a sexual event. The number of events between a 4-week baseline establishment period will be compared with the number of events during the 8 week double-blind treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.

Secondary Outcome Measures :

Sexual satisfaction [ Time Frame: 20 Weeks ]

Sexual satisfaction will be evaluated based on a global satisfaction assessment comparing the 4-week establishment period with the 8 week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.

Sexual desire and arousal [ Time Frame: 20 Weeks ]

Sexual desire and arousal will be evaluated based on the 'desire' and 'arousal' domains of the Sexual Anamnesis Questionnaire, the Sexual Function questionnaire and weekly diaries throughout the course of the study.

Sexual motivation and inhibition [ Time Frame: 20 Weeks ]

Sexual motivation and inhibition will be assessed using the Sexual Motivation Questionnaire and comparing sexual motivation and inhibition between the 4-week establishment period and the 8-week DB treatment period. In addition there is a 8 week run in period between the establishment period and the double blind treatment period for a total treatment period of 20 weeks.

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Ages Eligible for Study:

21 Years to 70 Years (Adult, Older Adult)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Provision of written informed consent

Female 21 to 70 years of age, inclusive, pre- or postmenopausal, with HSDD (comorbidity with female sexual arousal disorder and/or female orgasmic disorder [FOD; only as secondary diagnosis] is allowed). The diagnosis of HSDD will be established by a trained professional.

Low sensitivity for sexual cues

Be involved in a stable relationship and have a partner who will be at home for the majority of the study duration

Healthy according to normal results of medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity

History of myocardial infarction, stroke, transient ischemic attack, or life-threatening arrhythmia within the prior 6 months

Uncontrolled atrial fibrillation/flutter at screening or other significant abnormality observed on electrocardiogram (ECG)

Current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results, or which could form a contraindication for sildenafil and/or testosterone use

History of hormone-dependent malignancy

Vision impairment, such as partial or complete blindness or color blindness

History of (childhood) sexual abuse that, in the opinion of the investigator, could have negative psychological effects when testosterone is administered

(Treatment for) a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil and/or testosterone use

Current psychotherapeutic treatment for female sexual dysfunction

Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision).

A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study (Mild or moderate alcohol consumption is allowed but must be stopped 12 hours before the home measurement [Stroop task].)

Use of selective serotonin reuptake inhibitors, tricyclic antidepressants, or other antidepressants

Use of any other medication that interferes with study medication (eg, monoamine oxidase [MAO] inhibitors [includes classic MAO inhibitors and linezolid])

Use of medication (including herbs) that would compromise the validity of study results

Use of testosterone therapy within 6 months before study entry

Illiteracy, unwillingness, or inability to follow study procedures

Participation in other clinical trials within the last 30 days

Any other clinically significant abnormality or condition which, in the opinion of the investigator, might interfere with the participant‟s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for sildenafil and/or testosterone use